Thyroid Biopsy

THYROID BIOPSY WITH THE

RECIPROCATING PROCEDURE DEVICE

(RPD) © 2006,2007

Randy R. Sibbitt, M.D.1

Wilmer L. Sibbitt, Jr., M.D.2

1Department of Radiology

St. Peters Hospital

Helena, MT, USA

2Departments of Internal Medicine, Rheumatology and Neurology

University of New Mexico Health Sciences Center , Albuquerque, NM, USA

Educational Objectives

To review the indications for thyroid biopsy and thyroid cyst aspiration.

To understand the different forms of thyroid biopsy and their indications.

To understand the advances in technology in fine needle aspiration and cyst aspiration of the thyroid.

To understand and apply ultrasound-guided FNA and cyst aspiration using the RPD to the thyroid patient.

Evaluation and Biopsy of the Thyroid

Lesion

Adapted from eCure.com

Types of Clinical Thyroid Lesions

Palpable nodule or cyst.

Nodule or cyst on Ultrasound.

Euthyroid lesion.

Hyperthyroid lesion.

Hypothyroid lesion.

Cold euthyroid nodule on I131

Hot hyperthyroid nodule on I131

Hyperthyroid and Hypothyroid lesions may be managed medically first before biopsy.

Palpable Thyroid Lesion

Palpable Thyroid

Lesion

Cold NoduleHot Nodule

Hot Nodule

Contralateral

Lobe

Suppressed

Cold Nodule

Contralateral

Lobe Not

Suppressed

Hot vs.Cold Thyroid Lesions I131

Adapted from Lange et al Geneeskunde 2001;43 (2) and G Henneman, Chapter 13, Thyroid Disease Manager.

Hyperthyroid Lesions

Hyperthyroid lesions often require complex medical management.

Cold hyperthyroid lesions usually not biopsied until patient is euthyroid.

Hot hyperthyroid lesions are usually not biopsied but rather treated first with I131

ablation.

Hot hyperthyroid lesions or nodules are not usually appropriate for biopsy as an initial management step.

Cold Euthyroid Nodules

on I131 may be Cancer or Benign

Cold NoduleCold

Nodule

Adapted from Lange et al Geneeskunde 2001;43 (2).

Euthyroid Lesions

Euthyroid lesions can be cancer, benign neoplasms, cysts, or inflammatory.

Palpable euthyroid lesions can be biopsied with the palpation method or can be studied further with ultrasound.

Ultrasound visible simple cysts are only aspirated with they are symptomatic.

Ultrasound complex cysts and solid euthyroid lesions are often appropriately biopsied.

Risks for Thyroid Cancer

Enlarging painless lesion.

Multiple endocrine neoplasia II syndrome.

Cervical lymph node biopsy results consistent with thyroid cancer.

Prior head and neck radiation.

Past thyroid lobectomy for carcinoma now appearing as a nodule in the contralateral lobe.

Solid Lesion on Ultrasound in a Patient

with Previous Thyroid Carcinoma

Adapted from Titton et al: AJR 2003;181:26-271.

Color Doppler - Lesion with Reduced

Perfusion

Adapted from Rausch et al; J Ultrasound Med 20:79-84,2001

Thyroid Nodules and Thyroid Cancer

40% of the population has thyroid nodules by ultrasound.

Cystic lesions and solid lesions less than 1 cm in diameter are unlikely to be carcinoma and can be observed or biopsied.

Isolated hypoechogenic lesions, lesions with indistinct margins, or lesions with punctate calcifications have increased carcinoma risk and should be biopsied.

Mixed Solid Cystic Lesion on Ultrasound

Microcalcifications

Lesion BorderAdapted from Titton et al: AJR 2003;181:26-271.

Characteristics of Benign Thyroid Lesions

Typically isoechoic or echogenic.

Hypoechoic peripheral “halo” is characteristic but not an invariable or a specific finding.

Most benign nodules are either adenomas or colloid cysts.

Adenomas are often mixed solid and cystic lesions that may undergo internal hemorrhage to varying degrees.

Calcifications within benign nodules tend to be either of 2 types: (1) peripheral “eggshell” calcifications or (2) large, coarse calcifications.

Characteristics of Malignant Thyroid Lesions

A single hypoechoic lesion with indistinct margins,

With or without small punctate calcifications.

Gray scale US imaging differentiates benign from malignant nodules with sensitivities ranging from 75% to 87% and specificities ranging from 61% to 95%.

Vascularity is variable, and it is not possible to reliably differentiate benign from malignant nodules with color Doppler or US alone.

Thus, thyroid biopsy is frequently necessary.

Evaluation of a Thyroid Nodule

Thyroid Nodule

Measure TSH

“Hot” nodule

Pertechnetate Thyroid Scan

Fine Needle Aspiration (FNA)

TSH Suppressed

Radioiodine Ablation

or Surgery

Adapted from Mackenzie EJ et al: Chapter 6, MJA Practice Essentials

Nodule Cold

TSH Suppressed

National Institutes of Health: Evaluation

of the Euthyroid Lesion

Recommend biopsing suspicious palpable or US-visible euthyroid lesions 1 cm diameter or larger.

Recommend US as the imaging modality of choice for euthyroid lesions.

Recommend fine needle aspiration (FNA) biopsy as the thyroid biopsy procedure of choice.

Recommend repeat FNA for non-diagnostic specimens or inadequate specimens.

Recommend open biopsy only for malignant or suspiciously malignant cytology on FNA.

National Institutes of Health

Evaluation of Euthyroid Thyroid Lesions

Thyroid Nodule Ultrasound Identified Lesion

Fine Needle

Aspiration (FNA)

Complex Cyst Simple Cyst

Benign

Cytology

Follow

Non-Diagnostic OR

Inadequate Specimen

Repeat FNA

Malignant

OR Probably

Malignant

Open Surgical

Excisional BiopsyAdapted from the National Institutes of Health

Thyroid Biopsy Techniques

Open biopsy with complete or partial lobectomy - moderately dangerous.

Core needle biopsy - minimally dangerous.

Cutting needle aspiration biopsy - minimally dangerous.

Fine-needle nonaspiration biopsy (FNNA) -benign.

Fine-needle aspiration biopsy (FNA) -benign.

Open Thyroid Biopsy

Adapted from Majlis et al Rev. méd. Chile v.127 n.8 Santiago ago. 1999

Open Biopsy

Gold Standard

Can be curative.

Hazards include: general anesthesia, injury to recurrent laryngeal nerves, carotids, trachea,or parathyroid glands; hemorrhage, infection, cosmetic injury, death.

For most patients, a needle-based diagnostic technique is advantageous before open biopsy is planned.

Core Needle Biopsy of the Thyroid

Spring-Loaded US-Guided

Core Needle Biopsy of the Thyroid

Core biopsy is performed with a spring-loaded gun. Often a small incision is required.

The biopsy needle “springs” forward, cutting a “core” of tissue.

Core biopsy provides a larger piece of tissue, but also leaves a larger hole.

However, core biopsy has no greater sensitivity or specificity than FNA techniques.

Core biopsy results in a greater risk to surrounding structures and of hemorrhage. Thus, core biopsy is not the technique of choice for the thyroid.

Karstrup et al: Eur J Ultrasound. 2001;13:1-5.

Cutting Needle Aspiration Biopsy

Cutting Needle

Has a Stylet

Cutting Needle Aspiration

Biopsy of the Thyroid

Cutting needle biopsy is performed with a needle with a stylet. A typical example is a Chiba cutting needle. When the stylet is removed, suction is applied with a syringe to biopsy.

Cutting needle biopsy requires extra steps compared to FNA, and leaves a larger hole, resulting in greater hemorrhage.

Cutting needle aspiration biopsy is not superior to FNA in the thyroid, and thus is not the technique of choice.

Fine Needle Non-Aspiration (FNNA)

Biopsy of the Thyroid

Needle directed

Toward Target Lesion

Needle Used

Without a Syringe

Or SuctionAdapted from Gharib H, Chapter 6, Thyroid Disease Manager.

Fine Needle Non-Aspiration (FNNA)

Biopsy of the Thyroid FNNA is performed with a 25 gauge

conventional needle.

The needle is held in the fingers or placed on a syringe without a plunger.

The needle is directed at the lesion.

Multiple passes through the lesion are performed, and the needle is removed from the lesion.

The sample is attached to a syringe,expelled on a cytology slide, or into carrier/fixative solution, or sent to the pathology laboratory in the needle.

Fine Needle Aspiration of Thyroid

Vacuum Applied

with Device

Needle directed


Fine Needle Aspiration (FNA)

FNA is performed with a 25 to 20 gauge conventional needle and a syringe.

The needle is placed on a syringe.

The needle is directed at the lesion.

Once the needle is in the lesion, suction is gently applied.

Multiple passes through the lesion are performed, vacuum removed, and the needle removed from the lesion.

The sample is expelled on a cytology slide, or into carrier/fixative solution, or sent to the pathology laboratory in the needle.

FNA vs. FNNA: Which is Better?

FNNA? FNA?

Adapted from Gharib H, Chapter 6, Thyroid Disease Manager.

FNA vs. FNNA: Which is Better?

FNA and FNNA of the thyroid provide essentially the same sensitivity for malignant lesions. However, FNA is clearly superior to FNNA in all other tissues.

FNNA samples of the thyroid are smaller with fewer cells and of lesser volume.

FNNA is also insensitive to benign lesions of the thyroid and often does not provide adequate sample, thus more patients with FNNA have repeat FNA procedures and open procedures due to inadequate sample.

Thus, FNA is to be recommended over FNNA.

Findings on FNA: Neoplasm

Neoplasm 5% of the time.

Papillary Thyroid Carcinoma (70-80%).

Follicular Thyroid Carcinoma (5%).

Huerthle Cell Carcinoma (5%).

Medullary Carcinoma (5-10%).

Anaplastic Thyroid Carcinoma (3%).

Malignant Lymphoma (1-2%).

Metastatic Carcinoma (2-4%).

Findings on FNA: Benign

Lesions Benign 95% of the time.

Multinodular Goiter.

Hashimotos Thyroiditis.

Simple or Hemorrhagic Cysts.

Follicular Adenomas.

Subacute Thyroiditis.

FNA: Thyroid Medullary Carcinoma

Adapted from Dr. JC Prolla and Dr. Ada R. S. Diehl: Atlas of Histopathology

Dispersed atypical

cells ovoid and

triangular shapes

with fine granular

cytoplasm

FNA: Benign Colloid Nodule

Abdundant Colloid

(diffuse purple) and

Clusters of Epithelial

CellsAdapted from Rausch et al; J Ultrasound Med 20:79-84,2001

FNA: Thyroid Papillary Carcinoma


Papillary

Fronds with

Atypia

FNA: Squamous Cell Carcinoma


Malignant squamous

cells metastatic to

thyroid from primary

laryngeal carcinoma

FNA: Thyroid Follicular Carcinoma


Atypical

follicular Cells

FNA: Hashimoto’s Thyroiditis


Numerous

Well-

Differentiated

Lymphoid

Cells

FNA: Thyroid Primary Plasmacytoma


Plasma Cells

FNA: Benign Colloid Nodule

Sheets of

Normal

Thyroid

Epithelium

with Colloid


FNA: Huerthle Cell Carcinoma


Huerthle Cells

with large

nuclei and

prominent

cytoplasm

surrounded by

lymphocytes

FNA: Subacute Thyroiditis


Large

multinucleated

giant cells on

a background

of

lymphocytes

and little

colloid

How Effective Diagnostically is FNA?

o FNA is extremely effective diagnostically as follows:• 5% of biopsied thyroid nodules are malignant.• Approximately The diagnostic sensitivity for identifying

a lesion is 80-93% and the diagnostic specificity is 54-92%

• Positive predictive value of 50-90% and a negative predictive value of 92-95%.

• 18% malignancy rate for indeterminate or suspicious findings on FNA.

• More dangerous methods, including core biopsy, open biopsy, and cutting needle biopsy should only be used when FNA fails.

Hosler et al Diagn Cytopathol. 2006;34:101-5; Raber et al: Thyroid. 2000;10:709-12; Hatipoglu et al: Thyroid. 2000;10:63-9;Gharib et al: Endocr Pract. 1995;1:410-7; Liu et al:.Am Surg. 1995;61:628-32. Gharib et al: Clin Lab Med. 1993;1:699-709.

Who Performs Thyroid FNA?

o Generally, physicians as follows:

• Interventional and Ultrasound Radiologists (usually US-guided, occasionally CT-guided).

• Endocrinologists (palpation and US-guided).

• Otolaryngologists (usually palpation guided).

• Family practice (usually palpation guided).

Complications of Thyroid FNA

o Complications of Thyroid FNA are generally minimal, but include:• Hematoma, Pain, Bruising, Inflammation (common 5-10%,

benign).• Puncture of carotids (rare, life-threatening).• Progressive hematoma with respiratory compromise (rare,

life-threatening; requires surgical intervention).• Vascular proliferation of the thyroid (rare, dangerous).• Pneumothorax and pneumomediastinum (rare, occasionally

dangerous).• Abscess (rare, life-threatening).• Needle track seeding of tumor (rare, life-threatening).• Tumor and thyroid necrosis (rare, interferes diagnostically).• Vocal cord paralysis (rare, usually reversible).

Nishihara et al Thyroid. 2005;15:1183-7; Sun et al:Head Neck. 200224:84-6.; Pinto.et al: Acta Cytol. 1996;40:739-41.Gharib et al: Endocr Pract. 1995;1:410-7; Tomoda et al: Thyroid. 2006;16:697-9; Roh JL: Laryngoscope. 2006;116:154-6.

Noordzij et al:Am J Otolaryngol. 2005;26:398-9; Tsang et al: Arch Pathol Lab Med. 1992;116:1040-2.

THE

RECIPROCATING

PROCEDURE

DEVICE (RPD™)

The Reciprocating Procedure Device

(RPD) vs. Traditional Vacuum

Sources for FNA

Reciprocating Procedure Device (RPD).

The Conventional Syringe.

The Conventional Syringe with Plunger Lock.

The 3-ringed control syringe.

The Bio-Suk-7

Syringe Pistols

What is the RPD?

The RPD is a one-handed device that is functionally superior to and replaces the conventional syringe, control syringes, and syringe pistols for FNA. The RPD is better controlled and safer than previous devices.

Why Use the RPD for Thyroid FNA?

Most serious complications of thyroid biopsy are related to poor direction of the needle, resulting unintended puncture of a vital structure.

The RPD with one hand is better controlled than the traditional syringe, control syringes, syringe pistols and guns used with 1 or 2 hands.

Unlike syringe pistols and gun, the RPD is disposable, reducing infection risk.

Since the RPD is a one-handed device, the free hand can be used for other necessary tasks.

Carotid ArteryJugular Vein

SCM Muscle

Thyroid Lobe

Isthmus

Strap Muscle

Hazardous Anatomy for FNA


The RPD: Improved Outcomes for

Syringe Procedureso In physician-performed syringe procedures,

including FNA, the RPD results in:

• Greater accuracy and needle control.• Reduced patient pain and tissue trauma.• Reduced procedure time. • Improved tissue and fluid samples.• Facilitates physician-administered local

anesthetic.• Improved safety.• Superb vacuum control • Improved patient outcomes.

Expert Response:

The RPD is Safer for the Patient

Linda Williams, RN, MSI of the Veteran’s Administration National Center for Patient Safety noted,

“The design is marvelous in its own right, but it is also a great example of the best kind of safety solution.”

RPD vs. Conventional Syringe

1-Hand Aspiration 2-Hand Aspiration

1-Hand Injection 2-Hand Injection

RPD Clinical Trials

Clinical trials have demonstrated that the RPD is superior to the conventional syringe in terms of:

- physician control of syringe and needle

- aspiration of body fluids and tissues

- suction needle biopsy and thyroid biopsy

- arthrocentesis and intraarticular therapy

- administration of local anesthesia

The RPD consistently caused less patient pain and reduced procedure time.

From: J Rheumatol. 2006;33:771-8; J Vas Inter Rad 2007, Abstract 377;

J Vas Inter Rad 2005, Abstract 195

Physician Control of Syringe and Needle

Loss of Control in the Forward Direction

RPD with 1-hand is better controlled than the Traditional Syringe with 1 or 2 hands

0

2

4

6

8

10

12

14

16

18

20

1ml 3ml 5ml 10ml 20ml

1 handed

2 handed

RPD



mm

Physical Control of RPD:

Conclusions

The RPD markedly reduces unintended forward penetration (loss of control in the forward direction).

The RPD markedly reduces unintended retraction (loss of control in the reverse direction).

The RPD is superior to the conventional syringe at every size (1, 3, 5, 10, and 20 ml).

The improved control of the RPD results in significantly reduced patient pain, reduced procedure time, reduced perforation rates, and improved outcomes.



2.9± 1.3

1.9± 1.2

5.4± 3.1

1.7 ± 1.7

4.8± 1.2

8.9± 0.9

CCC

RRR

Aspiration of Body Fluids and Tissue:

The RPD vs. the Conventional Syringe

Procedure Time

32 % Reduction

P < 0.10

Patient Pain

67 % Reduction

P < 0.001

Physician Satisfaction

83 % Increase

P < 0.001

From: J Rheumatol. 2006;33:771-8;

Ann Rheum Dis. 2006;65:1084-7


Needle Procedures: Conclusions

In needle procedures, the RPD with one hand is superior to the conventional syringe with two hands or one hand.

Reduced patient pain and procedure time.

The RPD improves operator satisfaction.

The RPD provides greater sample yield with less trauma (hemorrhage).

The RPD is superior to the conventional syringe for aspiration of body fluid and tissue.

From: J Rheumatol. 2006;33:771-8; Ann Rheum Dis. 2006;65:1084-7


RPD demonstrated markedly improved needle control compared to plunger locks, syringe pistols, three-ringed control syringes, and dedicated biopsy syringes.

The RPD was able to control vacuum better than all these devices.

The RPD was able to eject the sample more easily than the above devices.

For FNA and cutting needle procedures the RPD was superior to other existing devices.

The RPD as a FNA Device

From: J Vasc Interv Radiol. 2006;17:1657-69.; J Vas Inter Rad 2007, Abstract 199;

Arthritis Rheum 2004:208 (209).

The RPD: Superior for FNA to Syringe

RPD Superior To

Syringe with 1-HandFrom: J Vasc Interv Radiol. 2006;17:1657-69.; J Vas Inter Rad 2007, Abstract 199;


RPD Superior To

Syringe with 2-Hands

The traditional syringe becomes longer with aspiration forcing needle forward. Limited control with 2-hands.

Poor control with 1-hand or two hands.

RPD demonstrates better control, less pain, and improved procedure outcome.

RPD shown to be superior in syringe procedures.

Disadvantages to Traditional Syringes



The RPD: Superior for FNA to Control Syringes

RPD Superior

To Plunger Locks

RPD Superior

To 3-Ring Control SyringeFrom: J Vasc Interv Radiol. 2006;17:1657-69.; J Vas Inter Rad 2007, Abstract 199;


Syringes becomes longer with aspiration forcing needle forward.

Plunger lock difficult to release vacuum.

Difficult to generate vacuum in 3-ring syringe.

RPD demonstrates better control than plunger locks and 3-ring control syringes during typical FNA procedures.

RPD is superior to plunger locks and control syringes.

Disadvantages to Control Syringes



The RPD: Superior to Biopsy Syringes

RPD Superior

To Bio-Suk

RPD Superior

To Reverse SyringesFrom: J Vasc Interv Radiol. 2006;17:1657-69.; J Vas Inter Rad 2007, Abstract 199;


Biopsy syringes becomes longer with aspiration forcing needle forward.

Requires major change in hand positioning when transitioning from aspiration to injection.

RPD demonstrates better control than the Bio-Suk-7 and reverse aspiration biopsy syringes.

RPD is superior to plunger locks and control syringes.

Disadvantages to Biopsy Syringes



The RPD: Superior to Syringe Pistols

INRAD Biopsy Gun Cameco Syringe Pistol



Major hand movement is required to generate vacuum.

Control is not with the fingers, but rather the base of the hand and arm.

Difficult to insert and remove syringe.

Syringe pistols violate OSHA Blood Bourne Infection Standards and promote spread of patient-to-patient and patient-to-physician viral, pyogenic, and prion infections.

RPD is better controlled than and superior to syringe pistols.

Disadvantages to Biopsy Guns and Pistols





In suction biopsy, the RPD was superior in control, generating vacuum, one-handed use, and clearing the sample from the biopsy needle.

The RPD was superior to the syringe pistol, dedicated biopsy syringes, three-ringed syringe, and conventional syringe.

The RPD was also superior for image guided thyroid biopsy and non-thyroid biopsy.

Biopsy: Conclusions

RPD: FNA of the Thyroid

Generation of Vacuum for FNA.

Control of the Needle in FNA.

Expelling sample for FNA.

Administration of Local Anesthesia -The RPD is less painful the a traditional syringe.

From: J Rheumatol. 2006;33:771-8; Ann Rheum Dis. 2006;65:1084-7;

J Rheum 2007;34:187-92; Journal Clinical Rheumatology 2007 (in Press)

The RPD was Compared to the Conventional Syringe

for Local Lidocaine Anesthesia in

150 Deep Needle Procedures

From: J Vasc Interv Rad 2007, Abstract 377

Conventional Syringe More Painful

and Less Effective for Local Anesthesia

RPD Less Painful and More

Effective for Local Anesthesia

Conventional Syringe RPD

Local Anesthesia: Conclusions

Administration of local lidocaine anesthesia is 30-40% less painful with the RPD as compared to the conventional syringe.

Anesthesia administration time is significantly reduced.

Local lidocaine anesthesia administered by the RPD is more effective than with a conventional syringe, presumably due to better anatomic placement and less trauma.

The RPD is superior to the conventional syringe for the administration of local anesthesia.

From: J Vasc Interv Rad 2007, Abstract 377

How is the RPD Different than a

Traditional Syringe?

The RPD is designed to provide better control of the needle than any existing syringe device.

The RPD is designed to provide superb vacuum control.

The RPD can be used to both aspirate and inject with effortless transition.

The RPD is designed to be operated with one hand so that the other hand can be used for other tasks during the procedure.

The RPD - Designed for Control

o The RPD is designed so aspiration and injection use the same finger motions and the strongest muscles of the hand - the flexors.

The RPD is designed so that the stabilizing digits, the index and middle fingers, do not change position when transitioning from aspiration to injection.

Design Differences Between the

RPD and Traditional Syringe

The traditional syringe consists of one barrel and one plunger; in the aspiration phase the plunger-syringe complex becomes longer forcing the needle forward into patient tissues.

The RPD because of its unique design does not become longer and does not force the needle forward, protecting patient tissues.

Traditional Syringe

RPD™Functional Barrel

Barrel

Injection

Plunger

Aspiration

PlungerAccessory Barrel

Plunger

Finger Flanges

Reciprocating

Mechanism

Components of the RPD vs.

the Traditional Syringe

The traditional syringe has no reciprocating mechanism.

The RPD has a reciprocating mechanismconnecting the two plungers. When the injection plunger is depressed the RPD injects; when the aspiration plunger is depressed, the RPD aspirates.

The mechanical linkage of the RPD causes the aspiration and injection plungers to reversibly “reciprocate” with each other.

Equipment for Thyroid FNA

1.5 inch 25 or 27 gauge needles.

Glass slides, frosted one end, 1mm thickness

Alcohol prep sponges.

Alcohol bottles for immediate fixing of slides.

Gloves

Containers for cystic fluid collection

Cytology lab slips with patient name, origin of sample, type of sample, date, tests to be performed.

Lidocaine 1% or 2%, very important.

Reciprocating procedure device (RPD) 5 ml or 10 ml for vacuum source.


LidocaineRPD

25 G Needles


RPDHistology Slides Alcohol Fixative

Prepare and Cycle RPD

Preparation for a Procedure

with the RPD

Remove the RPD from the sterile packaging.

Press the plungers, one at a time, and cycle the RPD through several reciprocation cycles to assure smooth functioning.

DO NOT PRESS BOTH PLUNGERS AT THE SAME TIME - EXCESSIVE FORCE MAY DAMAGE THE PULLEY MECHANISM.

DO NOT PULL PLUNGERS, ONLY PRESS.

Remove RPD from Sterile Packaging

Cycling The RPD

Through Several Cycles

Thumb moves

alternatively from

aspiration to injection

plunger

2. Attach Needle to RPD and

Use Appropriate Grip

Attach needle or other device to needle fitting of RPD.

Hold the RPD in 1-handed, 2-handed or trumpet grip.

Press the larger plunger to inject.

Press the smaller plunger to aspirate.

Use the RPD in any procedure where a traditional syringe would be used.

1. Attach Needle to

Needle Fitting

2. Hold RPD like a

traditional syringe

3. Press Reciprocating

Plungers to Aspirate

or Inject

2. Holding the RPD

One-Handed Standard Grip with RPD held between the index and middle fingers, and thumb operates the aspiration-injection plungers. The free hand is used for other tasks.

Two-Handed Standard Grip. Like the One-Handed Standard Grip, but the free hand is used to further stabilize the RPD or direct needle.

Trumpet Grip-One-handed. RPD held upside down, and index and middle fingers operate the aspiration-injection plungers like the keys of a trumpet. The free hand is used for other tasks.

Trumpet Grip-Two-handed. Like the One-Handed Trumpet Grip, but the free hand is used to further

stabilize the RPD or direct needle.

Aspirate with RPD

- the smaller plunger is

depressed with the

thumb

- index and middle

fingers on the finger

flanges

Inject with RPD

- the larger plunger is

depressed with the

thumb

- index and middle

fingers on the finger

flanges

One-Handed Standard Grip

InjectAspirate

AspirationInjection

Trumpet Grip

with the RPD

- To inject

the large plunger is depressed with the index finger

- To aspiratethe smaller plunger is depressed with the middle finger

- Used in certain anatomic situations.

RPD Played

Like Trumpet

Thyroid FNA with the RPD

Position patient with operator on side of patient.

Cover ultrasound transducer with sterile dressing.

Wear Gloves.

Ultrasound transducer transverse to lesion.

Local anesthetic with RPD on thyroid capsule.

Localize Lesion with Ultrasound

Lesion

Localize Lesion with Ultrasound

Anesthetize Thyroid Capsule

Local Anesthesia with the RPD

We recommend a 1 or 1.5 inch 22 gauge needle for aspirating drugs such as lidocaine.

Hold lidocaine vial with one hand, and RPD with other.

Pressing aspirating plunger, aspirate lidocaine into RPD.

Needle is dulled going through stopper and becomes more painful for patient. We recommend discarding aspiration needle, and switching to a fresh 25 gauge or 27 gauge needle of length appropriate for procedure.

3. Local Anesthesia with the RPD (cont).

Insert anesthesia needle mounted on RPD into target tissue.

Depress aspiration plunger of RPD and be certain there is no blood return into the needle hub, assuring extravascular positioning of needle tip.

If there is no blood return, slowly and cautiously inject lidocaine by pressing the RPD injection plunger. Repeat.

1. Aspirate Lidocaine 2. Insert Needle

3. Aspirate for Blood Return

before Injecting

4. If No Blood Returns, Inject

Lidocaine

US Transducer Thyroid

Lesion

25 or 27

gauge needle 5 ml or

10 ml RPD

Insert Needle Tip into Lesion

Insert Needle Tip into Lesion

Needle Tip

Needle Shaft

Adapted from Titton et al: AJR 2003;181:26-271.

Apply Vacuum with Needle in Lesion

Depression of RPD

Aspiration Plunger

Needle directed


The RPD for FNA

Generation of vacuum is important for FNA.

After the biopsy needle on the RPD is inserted into the target tissue, vacuum is generated by depressing the aspiration (smaller) plunger.

The vacuum is maintained by keeping the aspiration plunger depressed as multiple needle passes through tissue are obtained.

Prior to extracting the needle from the patient, the aspiration plunger is released, eliminating the vacuum and preventing the sample from being sucked into the barrel and trapped there.

4. General Instructions:

The RPD for FNA

Insertion of

Biopsy Needle

Into Target

Tissue

Generation

of Vacuum for FNA

Multiple Needle Passes

with Vacuum for FNA

Release of

Vacuum

Vacuum

Thumb Releases

Plunger

Thumb Depressing

Aspiration Plunger

After Vacuum Released Needle

Can be removed from patient

Depression of Aspiration Plunger

Needle with

FNA Sample

1. 2.

3. 4.

Release Vacuum and Lesion

Release RPD

Aspiration Plunger

Pull RPD and Needle

From Lesion

5. Expelling FNA Sample

Using the RPD

After the FNA, the tissue sample may need to be expelled to a cytological slide or container.

To accomplish this, the biopsy needle is removed.

The aspiration plunger is depressed, putting air into the RPD barrel.

The biopsy needle is reattached.

The injection plunger is depressed, expelling the tissue sample for cytological analysis.

Depression of

Aspiration Plunger

Air Enters

Functional Barrel

Functional Barrel

Filled with Air

1. Remove Needle

With FNA Sample

Needle With

Sample

2. Fill RPD

with Air

3. Reattach FNA Needle to RPD 4. With Needle Attached, Expel

FNA Sample

Depression of

Injection Plunger

FNA Sample

Expelled

From Needle

Preparation of Cytologic Slides

RPD1. Expel sample on Slide 2. Smear between slides

3. Immediately fix slides in alcohol

Apply pressure to biopsy site

Apply plastic adhesive strip.

After Biopsy Completed

How Effective is FNA with the RPD?

83 patients with a thyroid nodule underwent either FNA with the RPD or a core biopsy.

51 patients under FNA with the RPD.

32 patients underwent core biopsy with a spring loaded core device.

All samples were analyzed blindly by the cytopathologist.

Sibbitt RR et al: J Vas Inter Rad 2007, Abstract 199.

How Effective is FNA with the RPD?

The samples were classified as either diagnostic or inadequate-non-diagnostic, requiring an additional procedure.

All suspicious or definitely malignant aspirates resulted in open surgery.

Operating physicians rated ease of use, satisfaction, and effectiveness of the RPD for FNA.


6.9± 1.3

8.2± 1.2 81.5 % 83.2 %

18.5% 16.8 %

Core RCP

RESULTS:

RPD FNA vs. Core Biopsy of Thyroid

Physician

Satisfaction

P < 0.02

Diagnostic Biopsies

P > 0.1

Inadequate or Non-Diagnostic

Sample

P > 0.1

Core RCP Core RCP


CONCLUSIONS:

RPD FNA vs. Core Biopsy of Thyroid

FNA with the RPD is as effective as core biopsy for diagnosis of thyroid lesions.

FNA with the RPD is easier to perform and safer than core biopsy of the thyroid.

Operating physicians physicians rated the RPD was superior for FNA of the thyroid.

Based on this data, the practice group stopped using core biopsies of the thyroid and completely converted to FNA using the RPD.


The patents for the RPD are owned by the University of New Mexico. The RPD is protected by patents in both the USA and other countries.

The RPD is manufactured by

AVANCA Medical Devices, Inc.,

600 Central Ave SE, Suite 232

Albuquerque, NM, 87102 USA

www.AVANCAMedical.com

Tele: 505 243-4600

Fax: 505 243-4601

Patents

http://www.AVANCAMedical.com/

http://www.AVANCAMedical.com/

© 2006, 2007, Randy R. Sibbitt, MD and Wilmer L. Sibbitt, Jr., MD. All rights to images, text, graphs, and rights expressed and otherwise are retained by the authors.

Permission to use this presentation or portions of this presentation for educational purposes including presentations, educational publications, reviews, and scientific papers can be obtained from the authors.

Please contact the authors directly to obtain a PowerPoint version of the presentation at this email address: [email protected]

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